Shortening Adjuvant Photon and Proton Irradiation (SAPPHIRe-II): A 4 Cohort, Randomized, Phase II Multi-center Trial Evaluating Shorter Schedules of Adjuvant Regional Nodal Irradiation Among Women and Men With Node-positive and High-risk Node-negative Invasive Breast Cancer
M.D. Anderson Cancer Center
Summary
To learn about the effects of shorter RNI regimens in patients with breast cance who have had a lumpectomy or mastectomy and who are at higher risk for lower risk for the disease returning.
Description
Primary Objective: To compare the occurrence of any grade 2 or higher NCI CTCAE toxicity from start of RNI through 18 months follow up by treatment arm for each of the four randomized cohorts (low-risk lumpectomy, low-risk mastectomy, high-risk lumpectomy, high-risk mastectomy). Secondary Objectives: To compare treatment toxicity, local-regional control, disease-free survival, and overall survival by treatment arm for each of the four randomized cohorts. To compare patient-reported outcomes including cosmetic satisfaction, physical wellbeing, lymphatic function, and financial toxicity by t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Eligibility Criteria Applicable to All Cohorts Histologically confirmed invasive breast cancer (nodal involvement from presumed invasive breast cancer in the setting of occult breast cancer is sufficient to meet this criteria) 1\. Regional nodal irradiation recommended by treating radiation oncologist. 2 Negative final surgical margins. 3 No more than 12 weeks have elapsed since final breast/lymph node surgery for patients treated with surgery alone or neoadjuvant chemotherapy. No more than 12 weeks have elapsed since final cytotoxic chemotherapy for patients who receive…
Interventions
- RadiationUltrahypofractionated Radiation
Given by infusion
- RadiationModerately Hypofractionated Radiation
Given by infusion
Locations (3)
- Cooper Hospital University Medical CenterVoorhees Township, New Jersey
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas
- University of Texas Health Science Center at San AntonioSan Antonio, Texas